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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Cerilliant
Chinese Patent Office
US Army
Julphar
Accenture
Covington
McKinsey

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202191

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NDA 202191 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Roxane, Teva, Vistapharm, Wockhardt Bio Ag, Novel Labs Inc, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Par Pharm Inc, Sandoz, Schering, Sun Pharm Industries, Superpharm, Usl Pharma, Vintage Pharms, Watson Labs, and Yaopharma Co Ltd, and is included in fifty-three NDAs. It is available from forty-two suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are twelve drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 202191
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Novel Labs Inc
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202191
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 202191
Suppliers and Packaging for NDA: 202191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202191 ANDA Novel Laboratories, Inc. 40032-580 N 40032-580-31
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202191 ANDA Novel Laboratories, Inc. 40032-581 N 40032-581-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Aug 15, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Aug 15, 2014TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cipla
UBS
Colorcon
Boehringer Ingelheim
Chubb
Medtronic
Moodys
Daiichi Sankyo

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